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Comparison of Biolimus A9 and Everolimus Drug-Eluting Stents in Patients With ST Segment Elevation Myocardial Infarction (ROBUST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Masaryk University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Masaryk University
ClinicalTrials.gov Identifier:
NCT00888758
First received: April 27, 2009
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  Purpose

The primary objective of this study is:

  • comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups.

The secondary outcomes are a comparison of (using OCT):

  • number of uncovered stent struts
  • number of malapposed stents struts
  • in-stent neointimal volume
  • in-segment assessment of vessel wall response to DES

Condition Intervention Phase
Coronary Heart Disease
Percutaneous Coronary Intervention
 Device: biolimus A9
Device: everolimus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Masaryk University:

Primary Outcome Measures:
  • to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of uncovered stent struts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • number of malaposed stents struts [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • in-stent neointimal volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • in-segment assessment of vessel wall response to DES [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: biolimus A9
200 patients with STEMI will be treated using Biomatrix stent.
Other Name: biolimus A9 eluting stent
Active Comparator: 2 Device: everolimus
200 patients with STEMI will be treated with PROMUS DES.
Other Name: everolimus eluting stent

Detailed Description:

The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute STEMI within 12 hours from symptoms onset
  2. Native coronary disease with a lesion suitable for stenting
  3. Vessel size in between 2.5-3.75mm
  4. Patient is willing to provide written informed consent
  5. Male or female patients between 18-85 years of age

Exclusion Criteria:

  1. Significant left main disease
  2. Killip class IV
  3. Known allergy to aspirin and or clopidogrel/ticlopidine
  4. Recent bleeding (<1month)
  5. Patient in anticoagulant therapy
  6. No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel />3.75mm in diameter/)
  7. Pregnancy
  8. Severe liver or renal disease (Cr>2.0)
  9. Life expectancy < 1 year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888758

Contacts
Contact: Pavel Cervinka, MD,PhD +420477117886 pavel.cervinka@mnul.cz

Locations
Czech Republic
Department of Cardiology, Masaryk hospital and University of JEP Not yet recruiting
Ústí nad Labem, Czech Republic, 40113
Contact: Pavel Cervinka, MD,PhD     +420477117886     pavel.cervinka@mnul.cz    
Sub-Investigator: Petr Kala, MD,P hD            
Sub-Investigator: Ladislav Pesl, MD            
Sponsors and Collaborators
Masaryk University
Investigators
Principal Investigator: Pavel Cervinka, MD, PhD Krajska zdravotni a.s., Masarzk hospital Usti nad Labem
  More Information

No publications provided

Responsible Party: Assoc. prof. Pavel Červinka, MD, PhD, FESC, FSCAI, Masaryk hospital and University of JEP Ústí nad Labem
ClinicalTrials.gov Identifier: NCT00888758     History of Changes
Other Study ID Numbers: 06042006
Study First Received: April 27, 2009
Last Updated: April 30, 2009
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Masaryk University:
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Myocardial Infarction
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
 Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013